FDA BRIEF: Week of November 7, 2016

FDA Voice


The Race to bring Penicillin to the Troops in WWII

John SwannBy: John P. Swann, Ph.D., FDA Historian 

75 years ago..

The strain of Penicillium notatum that Fleming discovered at St. Mary’s Hospital in LondonFDA, academic, commercial, nonprofit, and governmental institutions raced to provide penicillin to WWII troops

  • Difficult to purify, scale up
  • US and Britain developed production modifications to increase yield by 100 fold
  • FDA technicians certified potency, absence of fever-producing contaminants, toxicity, sterility, and optimum moisture for stability
  • Participating firms increased purity and production for civilian needs as well

READ


Cochlear Implants: A Different Kind of ‘Hearing’

Cochlear implant

  • External part (behind the ear) + internal part (surgically placed under skin)
  • Magnet holds external system in place next to the implanted internal system
  • Receives sound, processes it, sends small electric currents to auditory nerve which signals brain
  • Can use as early as 18 m0.

FDA Regulation : Designated as Class III devices

Future:  Sophisticated technologies to minimize background noise, increase the noise-to-sound ratio, pairing with another cochlear implant or a hearing aid in other ear.

READ


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